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Cancer Genetics Wins 510(k) Clearance for Tissue of Origin Test

NEW YORK (GenomeWeb) – Cancer Genetics announced today that it has received special 510(k) clearance from the US Food and Drug Administration for its Tissue of Origin (TOO) gene expression test.

The microarray-based test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes, according to the company. It covers 15 common tumor types including thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin's lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.

The company said it received the approval after making modifications to test reagents and software.

"An important element of our recently implemented transformation strategy is the identification of new methods through which to monetize our world-class test portfolio," Cancer Genetics interim CEO and COO John Roberts said in a statement. "We are currently evaluating several partnering opportunities that would expand the reach of the TOO test and have the potential to generate high-margin revenue streams."

Earlier this month, Cancer Genetics disclosed that it is evaluating strategic opportunities — including raising additional capital, acquiring other firms and/or complementary assets, or selling itself off — following the departure of its former CEO Panna Sharma.

Also this month, Cancer Genetics was named in at least two class action lawsuits for allegedly making  false and/or misleading statements and/or failed to disclose information pertinent to investors.

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